[Federal Register Volume 68, Number 123 (Thursday, June 26, 2003)]
[Notices]
[Pages 38066-38067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16160]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0267]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Postmarketing Studies for Licensed Biological 
Products; Status Reports

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
requirements relating to FDA regulations for the postmarketing studies 
for licensed biological products.

DATES: Submit written or electronic comments on the collection of 
information by August 25, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.fda.gov/dockets/ecomments. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Management Programs (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed extension of 
an existing collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques when appropriate, and other forms of 
information technology.
    Postmarketing Studies for Licensed Biological Products; Status 
Reports (OMB Control Number 0910-0433)--Extension
    Section 130(a) of the Food and Drug Administration Modernization 
Act (Public Law 105-115) amended the Federal Food, Drug, and Cosmetic 
Act (the act) by adding a new provision (section 506B of the act (21 
U.S.C. 356b)) requiring reports of postmarketing studies for approved 
human drugs and licensed biological products. Section 506B of the act 
provides FDA with additional authority to monitor the progress of 
postmarketing studies that applicants have made a commitment to conduct 
and requires the agency to make publicly available information that 
pertains to the status of these studies.
    Under section 506B(a) of the act, applicants that have committed to 
conduct a postmarketing study for an approved human drug or licensed 
biological product must submit to FDA a status report of the progress 
of the study or the reasons for the failure of the applicant to conduct 
the study. This report must be submitted within 1 year after the U.S. 
approval of the application and then annually until the study is 
completed or terminated. The reporting requirements for applicants of 
approved new drug applications and abbreviated new drug applications 
are under Sec.  314.81(b)(2)(vii) (21 CFR 314.81(b)(2)(vii)). The 
collection of information requirements for Sec.  314.81(b)(2)(vii) are 
approved under OMB control number 0910-0001. The reporting requirements 
for applicants of approved biologics license applications (BLAs) or 
supplements to an application are under Sec.  601.70 (21 CFR 601.70).
    Section 601.70 requires applicants of approved biologics license 
applications or supplements to an application to submit to FDA 
postmarketing status reports for studies of clinical safety, clinical 
efficacy, clinical pharmacology, and nonclinical toxicology that are 
required by FDA or that an applicant of a BLA commits to conduct, in 
writing, at the time of approval of an application or a supplement to 
an application, or after approval of an application or a supplement. 
Information submitted in a status report for Sec.  601.70(b) is limited 
to that which is needed to sufficiently identify each applicant that 
has committed to conduct a postmarketing study, the status of the study 
that is being reported, and the reasons, if any, for the applicant's 
failure to conduct, complete, and report the study. Previously, status 
reports were only for postmarketing studies in pediatric populations. 
Section 601.28(c) (21 CFR 601.28(c)) requires that the status of 
postmarketing pediatric studies be reported under Sec.  601.70 rather 
than under Sec.  601.28 and therefore, the information collection 
burden for postmarketing studies in pediatric populations is included 
under Sec.  601.70.
    Respondents to this collection of information are the applicants 
holding approved applications for licensed biological products that 
have committed to conduct postmarketing studies. Based on information 
obtained from FDA's Center for Biologics Evaluation and Research 
computerized application and license tracking database, the agency 
estimates that approximately 44 applicants with 65 approved BLAs have 
committed to conduct approximately

[[Page 38067]]

223 postmarketing studies and would be required to submit an annual 
progress report on those postmarketing studies under Sec.  601.70. 
Based on past experience with similar reporting requirements, the 
agency estimates that it takes an applicant approximately 24 hours (8 
hours per study x 3) annually to gather, complete, and submit the 
appropriate information for each report (approximately two to four 
studies per report). Included in these 24 hours is the time necessary 
to prepare and submit two copies of the annual progress report of 
postmarketing studies to FDA under Sec.  601.70(d).
    FDA estimates the burden for this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                               Annual Frequency per       Total Annual
            21 CFR Section               No. of Respondents          Response              Responses          Hours per Response        Total Hours
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601.70(b) and (d)                                   44                      1.5                   65                     24                  1,560
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: June 16, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16160 Filed 6-25-03; 8:45 am]
BILLING CODE 4160-01-S